Events

Alerte De Sécurité sur FrameArray Module HZ7 and Floorstand HZ5

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Varian Medical Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2011-10-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111007.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Urgent field safety notice: varian framearray module hz7 and floorstand hz5 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning head ring posts used by both the framearray module (of the optical guidance platform) hz7 and floorstand hz5, where the head ring posts may be damaged due to excessive mechanical stress, resulting in possible failure during usage. this could result in the movement of the headring relative to the patient’s anatomy. according to the supplier, the affected devices have been distributed in hong kong. varian is sending a notification letter to affected users to remind them to inspect their head ring posts and verify that they are using the current design and that it is labeled with the part number 970.284. if the posts are not labeled 970.284, customers should discontinue use and contact varian service for replacement. varian will also arrange an inspection of all head ring posts and replace affected units.

Device

FrameArray Module HZ7 and Floorstand HZ5
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian FrameArray Module HZ7 and Floorstand HZ5
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems